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The European Medicines Agency’s plans for sharing data from clinical trials

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Prescrire has recently written to the Director of the European Medicines Agency after having been denied access to administrative documents.

The EMA argues that the ongoing legal proceedings before the European Court of Justice are preventing the agency from implementing its policy on access to documents. Prescrire is appealing that decision.

In its refusal letter, the EMA cites the need to protect commercial interests. Yet our requests pertain to clinical data and to drug packaging, which are matters of public interest. If citizens in Europe are to enjoy the best healthcare possible, then the EMA access-to-documents policy must be ambitious.

The EMA should continue its new openness policy despite current lawsuits

Open letter
To Guido Rasi, Executive Director of the EMA

Dear Guido Rasi,

The Nordic Cochrane Centre has for more than a year now received clinical study reports and protocols from the EMA for duloxetine, an anti-depressant drug marketed by Eli Lilly. These reports have been highly valuable for our research and will also benefit public health, as they are more comprehensive and less biased than what Eli Lilly has published in medical journals.

We are continuing our research in this area but the EMA wrote to us on 17 June 2013 that we cannot get the remaining reports on duloxetine:

"The Agency's Policy has not been the object of detailed analysis by the President of the General Court. However, in light of the on-going legal proceedings, in particular, the Court's consideration of whether disclosure of the sort documents you have requested might undermine the commercial interests of a natural or legal person as laid down in Article 4(2) of Regulation (EC) No 1049/2001, please be informed that the Agency cannot grant access to the following documents..."

We note that the current cases at the General Court of the European Union do not involve duloxetine or Eli Lilly but two other companies, AbbVie and Intermune, and concern biologicals.

When we asked the EMA in 2007 to share the clinical study reports and protocols for orlistat, an anti-obesity drug, with us, our request was turned down by the EMA's former director, Thomas Lönngren. We appealed Lönngren's decision to the European ombudsman who inspected the reports we requested and concluded that they did not contain commercially confidential information (1). After the ombudsman had criticised the EMA for its decision, we were granted access in 2010. This case is the basis for the EMA's new openness policy, which we wholeheartedly support, as it will lead to tremendous progress in public health, less harm caused by drugs, and economic savings for the European Union.

We believe we are now at a watershed. The public's confidence in the drug industry's working practices has never been lower, and it is clear that the business model of big pharma is organised crime, which is immensely harmful to our citizens (2). It is also true that drugs are the third leading cause of death in Europe and the United States, after heart disease and cancer, and that the lack of access to the clinical trial data to a considerable extent is responsible for this public health disaster (2).

We must do - and can easily do, if we get access to the data - better than this and we should not allow drug companies to bully our societies, patients and public institutions with their lawyers. The current cases at the European Court could potentially take years before they are resolved, and we should not accept that the EMA's new openness policy is put to a halt in the meantime because of shameful court cases filed by two drug companies who evidently put profits over patients.

On a more practical note, we should have received the remaining duloxetine files a long time ago, but fully understand that the increased workload that the EMA's new openness policy has created for the agency has caused delays. It seems that Eli Lilly has not protested earlier when the EMA informed the company that it intended to send the reports on duloxetine to us, most of which we have already received. It is therefore highly unlikely that Eli Lilly would now drag the EMA to court, just because the EMA decides to send us the remaining few files on duloxetine. And even if it did, the EMA should be prepared to defend the patients' rights to trustworthy information about drugs.

Whether it comes from the mob or from the drug industry, organised crime is very serious and it must be fought with all posssible means. If we give in to it, we also accept its hugely damaging influence on our societies, including the many deaths it causes.

The EMA's letter of 17 June 2013 to us refers to an EMA press release from 30 April 2013, which states that:

"Pending the outcome of the final judgement on the main cases, the EMA will continue with its policy to grant access to documents."

I therefore suggest you do exactly this and send us the few remaining files. I also suggest that the EMA continues to send files and information other parties ask for, like the EMA has done on an ongoing basis since 2010. We should not be afraid when people who engage in organised crime send their lawyers. We must all stand firmly behind the good cause we are defending.

Not many clinicians or scientists would argue with the campaign by "All Trials" to register and report the full methods and the results of clinical trials.1 But is it sensible to go so far as to "..encourage authors of all BMJ papers to share their datasets publicly..", so that all may see?2

We routinely reassure participants in clinical trials that their data will be held securely and confidentially. Research ethics committees rightly insist on locked filing cabinets, and only the researchers having access to digital data. Is this reassurance consistent with public release of patients' confidential data without their consent? Although only "anonymised" data are proposed for public release, is data truly anonymous when details of age, gender and perhaps locality are linked to past and current medical histories; data often collected in trials to examine moderators and mediators of efficacy?

And what will potential trial participants of the future think of the reassurance of confidentiality when they know that their "anonymised" data will be publicly available for anyone to access? Will this encourage more patients to take part in trials, or will this have the opposite effect?

I prefer the Medical Research Council's current policy on access to research data; consider release only to bona fide researchers, working for bona fide research organisations, who sign up to the same standards of respecting the confidentiality of the data as the original researchers.3

Competing interests:
I have received a number of Freedom of Information requests from members of the public for all the data from a recent trial of non-pharmacological treatments of chronic fatigue syndrome.

In an article in this week's European Voice I describe how the two companies, in their previous activities, have themselves shown the need for full disclosure.
The text of the article can be found through my blog